Cover Story
Safety First
How anesthesiologists launched the patient-safety movement.
By Kate Ledger
For Mayo Clinic anesthesiologist Mark Warner, M.D., one of the most harrowing moments of his career also turned out to be among the most significant. It happened in 1988, as Warner began administering an anesthetic to a 60-year-old patient who was undergoing surgery to remove bladder tumors. The anesthetic was sodium pentothal, which was then widely used in the OR. What nobody could have anticipated was that the patient would have a severe allergic reaction to the anesthetic, sending him into cardiac collapse. The OR team conducted CPR for an hour and 15 minutes, to no avail.
They were about to conclude their resuscitation efforts when Warner recalled an article he’d read just days before that offered another lifesaving tactic. It explained how a large quantity of epinephrine (more than 5 mg) could treat anesthesia-related anaphylactic shock. “It was a much larger dose than I’d ever given,” Warner remembers. But he turned to this technique as a last-ditch effort to save the man’s life. It worked.
For Warner, that close call in the OR underscored the importance of a new movement that was underway. Only three years earlier, the American Society of Anesthesiologists (ASA) had established the Anesthesia Patient Safety Foundation (APSF). Leaders of the two organizations had begun to gather reports of adverse events such as allergic reactions to anesthetics, equipment malfunctions during surgery, and tragic medical errors and oversights. They had begun to publish articles about those events and see them as trends requiring rigorous study. “Until then,” says Warner, who recently became president of the ASA, “incidents would happen in isolated settings. Each event might prompt a change in an approach; but nobody was pulling all the cases together and looking at entire systems and asking, What can we do better?” He recognized that unprecedented, and potentially life-saving, information was becoming available to the field. What he only could have guessed at the time was that the new focus on patient safety would have a major impact not only on the practice of anesthesiology but on other medical specialties as well.
An Age-Old Hazard
The notable dangers of anesthesia go back to the beginning of modern surgery. In the 1920s, a patient had a one in 10 chance of surviving a procedure such as an appendectomy because of the risks of anesthesia as well as of postoperative infections. Survival rates eventually improved. But even 40 years ago, anesthesia-related mishaps in Minnesota and across the country were more common than anyone wished.
Some were the result of human mistakes. In one case from the late 1970s, a 45-year-old woman with severely disfiguring rheumatoid arthritis died on the operating table during an orthopedic procedure on her shoulder. The anesthesiologist had placed an oxygen tube through her nose into her trachea. At the time, physicians ascertained placement of the tube by listening with a stethoscope for the flow of air. Despite what sounded like air going in and out of the woman’s lungs, the tube was misplaced.
Other problems arose from equipment in the OR. Some had components that made it possible for an anesthesiologist to inadvertently turn on two potent anesthetic gases at once. In the 1980s, such a mishap caused the death of a 20-year-old patient who received both enflurane and halothane at once. In another case, a canister of volatile gas was knocked over and then put back on a shelf. The tipping caused too much gas to flow into the canister’s vaporizing compartment; as a result, a pediatric patient received an excessive dose of anesthesia. Similar adverse events were happening throughout the country. (In some cases, they resulted in the manufacturer swiftly making improvements to anesthesia machinery.) By some accounts, as many as 6,000 people in the United States were being harmed each year.
More common than accidental deaths were “near misses,” recalls Richard Prielipp, M.D., chair of anesthesiology at the University of Minnesota. Most anesthesiologists had stories about narrowly avoiding an incident during surgery. “Often, patients didn’t actually suffer permanent harm, but they were very close to it,” he says, noting that the day-to-day work environment for anesthesiologists was markedly tense. “I think we had a sense that you were always close to the edge [of something unwanted happening], or not knowing how close to the edge you really were.”
Adding to the tension was the fact that liability payouts from anesthesia accidents were exorbitant. The cost of malpractice insurance for anesthesiologists was among the highest of all medical fields, ranging from $35,000 to $50,000 a year across the country in the mid-1980s. “Insurance was in range of other specialties that were considered high-risk, including neurosurgery and obstetrics,” says Steve Sanford, president of Preferred Physicians Medical, a Kansas company that specializes in coverage for anesthesiologists. What many anesthesiologists realized was that the burdensome rates turned talented medical students off to the discipline.
Bringing the Worst to Light
The turning point for the field occurred in 1982, when then-president of the ASA, Harvard’s Ellison “Jeep” Pierce, M.D., focused attention on what had long been an unspoken issue. Pierce had an interest in patient safety, stemming from a lecture he delivered as a junior faculty member in 1962. He had even saved clippings over the years about anesthesia accidents. But when the prime time television program “20/20” warned consumers in 1982 about the great risks of dying or suffering brain damage from modern-day anesthesia, Pierce took the opportunity to show that his field could step up. He pushed for the creation of a safety committee within the ASA.
That same year, a seminal article appeared. It compared human error in aviation accidents to errors in anesthesia. When the paper was presented at an international conference in Boston, anesthesiologists from all over the world were captivated. A group of them, including Pierce, gathered after the conference ended and decided to create the APSF, which would be funded by the ASA along with companies that produced machines and drugs for anesthesia. The new organization would sponsor studies of anesthetic injuries, encourage the creation of programs aimed at reducing accidents, and get the word out swiftly about the causes of injuries and ways to prevent them.
A subcommittee of the ASA also established what was called the Closed Claim Project, working with insurance companies to release anesthesia information from malpractice cases. The committee reviewed hundreds of disastrous anesthesia events and began to publish articles about recurrent problems. Suddenly, information was becoming available, such as the article about high-dose epinephrine that Warner had encountered.
The newly abundant and unflinching literature also led to the development of new technology designed to improve patient monitoring and safety. Two critical breakthroughs immediately became the standard of care. One was the introduction of the pulse oximeter, which had been in production for several years but hadn’t yet been introduced to clinical settings. The finger-clip that detects the percentage of oxygen saturation in the blood enabled anesthesiologists to easily monitor a patient and stem a crisis quickly. The second was a device that could measure the quantity of carbon dioxide in a patient’s exhalation, finally offering a scientific means to determine whether breathing tubes had been properly placed. “The decrease in the number of adverse events was dramatic,” Warner notes of the introduction of these devices.
Information from the Closed Claim Project also led to new studies. One at Mayo, for instance, investigated more than 200,000 nationally reported occurrences of pulmonary aspiration during surgery, looking at the frequency of food and acidic fluid from the stomach entering the airways and blocking breathing or causing inflammation in the lungs. Researchers looked specifically at timing: When, in the process of surgery, did aspiration occur? They established guidelines to determine how long before surgery patients could safely eat and also found, contrary to previously held beliefs, that drinking water before surgery can be helpful for patients. In a range of anesthesia journals, researchers began publishing articles about safety issues, from dangerous, volatile gas interactions to infections caused by anesthesia equipment.
Organized and Diligent
In 1999, the Institute of Medicine recognized the APSF as an organization that had made significant advances in patient safety; in fact, the APSF became the model for the National Patient Safety Foundation, a similar organization touching all disciplines that was founded that same year. In Minnesota, the growing national push to improve safety measures turned into specific statewide expectations for hospitals. In 2000, a committee that included representatives from the Minnesota Medical Association, the Minnesota Hospital Association, and the Minnesota Department of Health gathered to form the Minnesota Alliance for Patient Safety and began meeting to determine what could be done to reduce accidents and adverse events. Three years later, Minnesota became the first state in the country to require hospitals to report occurrences of 28 different adverse events (26 states have since adopted a mandatory reporting system; one has a voluntary system). “The reporting system serves to hold facilities’ feet to the fire,” says Diane Rydrych, assistant director of the Minnesota Department of Health’s division of health policy. “It also gives consumers information that they can use to ask questions about what’s being done about events and what’s being done to prevent them. But we really look at what we can learn from the data all the time; we’re always looking to see if there are trends.”
One unfortunate problem that turned up in Minnesota in recent years is conducting surgery on the wrong part of the body. Across the state last year, 31 wrong-site procedures took place. Approximately 30 percent of them were anesthesia-related problems such as performing a regional block for pain on the wrong knee. A statewide initiative is now in place to work on eliminating wrong-site procedures. More than 100 hospitals and surgery centers are currently involved.
In the past, surgeons typically marked the operating site with initials. Now, anesthesia is being brought into the loop, with anesthesiologists viewing documentation before surgery and also marking the location where drugs will be administered. What’s more, the entire OR team—surgeons, anesthesiologists, and nurses—now conduct periodic “time out” pauses in which members of the team stop what they’re doing to review the identity of the patient and the location of the procedure site.
Since the collaborative effort known as the Safe Site Statewide Initiative was launched three years ago, hospital adherence to “best practices” (the steps to reduce wrong-site procedures) has increased: The percentage of hospitals with safety steps now in place has jumped from 59 percent to 96 percent. Many believe the reason the number of adverse events has not yet dropped is that heightened awareness of the problem has increased hospital reporting of these incidents, particularly those involving anesthesia. “There’s more awareness that wrong-site anesthesia is a reportable occurrence and that we can learn from it and to try to eliminate it,” says Julie Apold, director of patient safety for the Minnesota Hospital Association.
Practicing Safety
There’s no doubt anesthesia’s focus on patient safety has produced improvements: Nationally, the number of deaths per anesthesia administration plummeted from one in 10,000 in the mid-1980s to one in nearly 200,000 today. In addition, surgeries have become safer because the drugs have improved. “We have better, shorter-acting anesthetic and adjuvant drugs with fewer side effects,” says the University of Minnesota’s Prielipp. With agents such as propofol that induce anesthesia quickly and narcotics and muscle relaxants that don’t linger, “we can now titrate the endpoints of anesthesia much more precisely,” he says. The technological advances in patient monitoring have decreased the “near misses” and improved the tenor of the work environment. And annual malpractice insurance premiums for anesthesiologists have plummeted since the mid-1980s; they now average about $18,000 nationally. Prielipp says that has boosted interest in the field among trainees.
As an organization, the ASA has continued to actively spread its message about patient safety. As part of the World Federation of Societies of Anesthesiology, it has been trying to raise approximately $80 million to make life-saving devices such as the pulse oximeter available in hospitals all over the world.
In this country, guidelines that involve the use of checklists, preoperative team meetings, and periodic time outs in the OR are now in place in many operating rooms, including those at the University of Minnesota, says Barbara Gold, M.D., vice president of clinical safety with University of Minnesota Physicians. “We’ve adopted many proven methodologies, borrowing heavily from the aviation industry and others that have a narrow margin for safety. We’ve also looked to human factors analysis, a branch of industrial engineering that looks at the interface of humans and machines, how the behavior of humans can be managed to reduce error,” she says. Teamwork, which anesthesia has always promoted, has evolved as a necessity for safety.
Aiming Low
Anesthesiologists agree that there’s still work that needs to be done to improve patient safety. Some changes that need to happen are simple ones such as having mandatory preoperative meetings—a sort of team huddle to review the surgical plan and to discuss any comorbidities the patient has that may complicate the case. Others are more complex such as using a bar-code reader (still in development) that verifies drugs in order to prevent the delivery of the wrong medication. “We’re shooting for a zero-defect service, using the language of industry,” Prielipp says, “and we won’t be satisfied until no patients suffer any harm or injury associated with surgical and perioperative anesthesia.” MM
Kate Ledger is a St. Paul writer and frequent contributor to Minnesota Medicine.
Simulating Surgery
In the mid-1990s, anesthesiologists in San Francisco began developing high-fidelity computerized mannequins that stand in for patients and can be used for training. More sophisticated than the familiar resuscitation dummies used for First Aid training, these computerized models have a pulse, can open their eyes, and can make breathing motions. And they react with physical responses such as plummeting blood pressure, which can be modified by computer to represent crisis scenarios.
Use of such technology is taking off at many academic institutions around the country, and Minnesota is home to a number of simulation centers including one at Mayo Clinic, one at the University of Minnesota, and one at Regions Hospital in St. Paul, which is owned by HealthPartners.
The idea of simulation—actually practicing how to respond in the rarest of adverse events—has broadened beyond anesthesia to include entire health care teams. At the university, a simulation lab offers OR personnel the opportunity to run through patient crises. The university is working to get approval from the American Society of Anesthesiologists to make the site a nationally recognized simulation training center that will draw physicians and nurses from around the country to run through worst-case scenarios.
One event that can be simulated is a patient experiencing anaphylaxis. Another is a fire in the surgical suite caused by gases igniting in the presence of electricity. “We have a scenario that specifically teaches people how to prevent fires by avoiding certain solutions or to employ precautionary measures like using lower oxygen flows, and then, in spite of all preventative efforts, if it happens, to react by turning the oxygen off, disconnecting the source of oxygen, and putting the fire out,” says anesthesiologist Mojca Konia, M.D., clinical director of the anesthesiology and critical care simulation lab.
Fidelity to realism is critical, says Mayo anesthesiologist Laurence Torsher, M.D., co-director of the Mayo Clinic Multidisciplinary Simulation Center. Since it opened in 2005, approximately 31,000 health care practitioners from throughout the Mayo system have been trained at the center, which has six standard patient rooms, a task-trainer room, and three rooms that can be set up as exact replicas of an OR, an emergency room, or an intensive care unit, complete with the clinical equipment and medications found in each site. “You can read about what to do in an adverse event, but when you’re in that situation, your hands need to know how to open the medication you need,” Torsher says.
In addition to offering training in its 7,000-square-foot simulation center, called HealthPartners Clinical Simulation, HealthPartners has taken its high-fidelity mannequins and equipment to other locations including hospitals in western Wisconsin and Maple Grove to run teams through simulated emergencies. “Besides clinical skills, we’re testing teams’ approaches to communication and how their system of care is designed in order to make it more efficient and safe,” says Carl Patow, M.D., M.P.H., executive director of HealthPartners Institute for Medical Education. Last year, HealthPartners used its simulation resources to train more than 4,300 providers and students.
Although data about whether simulation reduces adverse events is still being collected, Torsher and a team from Mayo recently published a case study in the journal Anesthesia and Analgesia describing what happened when a sedated patient suddenly experienced cardiac toxicity and required resuscitation in the recovery room. The team had recently practiced exactly that scenario in the simulation center. “The resuscitation of the patient went seamlessly,” Torsher says.—K.L.